| CTRI Number |
CTRI/2009/091/001008 [Registered on: 15/06/2010] |
| Last Modified On: |
19/03/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
BA/BE |
Type of Study
Modification(s)
|
Not applicable |
| Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A study to assess the effect of oral insulin on safety, tolerability, effect of oral insulin on the blood sugar level and effect of oral insulin on the body in typeI Diabetes mellitus patients. |
Scientific Title of Study
Modification(s)
|
An Open Label, Multicenter, Non-randomized, Active Controlled, Single Dose Escalation, Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of IN-105 under Fed Conditions in patients with Type 1 Diabetes Mellitus. |
| Trial Acronym |
TIDM |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| IN105-CT1-005-09 (V1.02 09 July 2010) |
Protocol Number |
| NCT01035801 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Prasanna Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Bangalore Diabetes Hospital |
| Address |
#16/M,Miller Tank Bed Area, Thimmaiah Road
Vasanthnagar Bangalore Karnataka
Bangalore
KARNATAKA
560052
India |
| Phone |
08022372980 |
| Fax |
08022372981 |
| Email |
dr.kmpk@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Vinu Jose |
| Designation |
Chief Scientific Manager |
| Affiliation |
Biocon Research Limited |
| Address |
Plot no 2 and 3, PhaseIV BIA
Bommasandra Jigani Lnk road
Bangalore
KARNATAKA
560099
India |
| Phone |
08022372980 |
| Fax |
08022372981 |
| Email |
Vinu.Jose@biocon.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Famida Khan |
| Designation |
Principal Scientist |
| Affiliation |
Biocon Research Limited |
| Address |
Plot 2 and 3 Phase IV
BIA Bommasandra Jigani Link Road
Bangalore
KARNATAKA
560100
India |
| Phone |
08028085319 |
| Fax |
08028085323 |
| Email |
Famida.Khan@biocon.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Biocon Research Limited |
| Address |
Plot no 2 and 3 Phase IV BIA Bommasandra Jigani Link Road Bangalore Karnataka India 560099 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Not applicable |
Not applicable |
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KM Prasanna Kumar |
Bangalore Diabetes Hospital |
#16/M, Miller Tank Bed Area 560052
Bangalore
KARNATAKA |
08022372980
08022372981
dr.kmpk@gmail.com |
| Dr. Neeta Deshpande |
Belgaum Diabetic Centre |
Ground floor,Beside mahila Vastu Bhander,Maruti Gali-590001
Belgaum
KARNATAKA |
08312422668
neetarohit@gmail.com |
| Dr Sanjay Kalra |
Bharti Research Institute of Diabetes and Endocrinology, |
Bharti Hospital, Wazir Chand Colony, Kunjpura, ,-132001
Karnal
HARYANA |
01842268484
01844046554
bridelknl@gmail.com |
| Dr Bipin Sethi |
Care Hospital |
Road 1,Banjara Hills, ,-500034
Hyderabad
ANDHRA PRADESH |
+91 4066258792
bipinkumarsethi@yahoo.co.uk |
| Dr. S.R. Aravind |
Diacon Hospital, |
(Diabetes Care and Research Centre),-560010
Bangalore
KARNATAKA |
080 23130553
080-23130553
aravindsosale@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Bangalore diabetes ethics committe situated in Bangalore. Dr Prasanna Kumar is the PI. |
Approved |
| Clinicom Ethics Committe is located in bangalore. Dr Neeta is the PI . |
Approved |
| Diacon Hospital Ethics Committee is located in bangalore. Dr Aravind SR is the PI. |
Approved |
| IInstitutional ethics committe for Bride located in karnal haryana. Dr Kanjay is the PI |
Approved |
| Institutional Ethics committee Care hospital located in hyderabad. Dr Bipin Sethi is the PI |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 1 Diabetes Mellitus, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
IN-105 |
10mg, 20mg, 30mg and 45 mg
Mode of administration - oral
Frequency - single dosing. |
| Comparator Agent |
Insulin Lispro |
Dose used by the subject/patient earlier to the start of the trial.
Method of administration - subcutaneous
Frequency of administration- single dosing |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Day(s) |
| Age To |
45.00 Day(s) |
| Gender |
Both |
| Details |
1.Ready for written informed consent.
2.Patients of either gender between 18 to 45 years inclusive.
3.Established diagnosis of TIDM.
4.Body mass Index of 18.5-29.9kg/m2 inclusive.
5.Stable weight.
6.Glycosylated Haemoglobin (HbAIC) 8.0%at screening.
7.On stable insulin or an insulin analogue regimen for atleast 3 months. |
|
| ExclusionCriteria |
| Details |
• History of hypersensitivity to active or inactive ingredients of the drug
• Significant history of atopy or allergic drug reactions.
• Abnormal lab parameters – urine, ECG, hepatic and renal function
• History of drug or alcohol dependence or abuse within 6 months prior to screening.
• Insulin resistance
• Patients on glucocorticoids, other blood-glucose lowering drugs
• Uncontrolled hypertension and hyperlipidemia
• Evidence of severe secondary complications of diabetes
• History of hypoglycemia or hypoglycemia unawareness
• Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening.
• Diseases like coronary artery disease, history of stroke, hematological disorders, planned surgery
• Pregnancy, lactation, or planned pregnancy
• The patient has received another investigational drug
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| AUC ratio from 0-130 min for PK and PD with Lispro for different doses |
0-130 min |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Other PK primary and secondary parameters, PD and PK ratio of AUC at different other time intervals till 250 min
Safety and tolerability
|
0-70min, o-190 min and 0-250 min |
|
Target Sample Size
Modification(s)
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
01/08/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/08/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is planned to compare the pharmacokinetics and pharmacodynamics of Lispro with different doses of IN105 in T1DM patients. Data analysis is ongoing. |